The Recall Desk

Manufacturer

Fougera Pharmaceuticals, Inc.

8 recalls in our database name Fougera Pharmaceuticals, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2017-03-29

Of the 8 recalls from Fougera Pharmaceuticals, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • ModerateFDA (Drugs)·D-0612-2017·2017-03-29

    Fougera Recalls Desonide Ointment Tubes Due to Labeling Mixup

    Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.

    Product
    Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0245-2015·2014-11-19

    Fougera Recalls Fluocinonide Gel Due to Residual Solvent Concerns

    Fougera Pharmaceuticals is recalling specific lots of Fluocinonide Gel USP, 0.05% because they may not meet USP requirements for residual solvents.

    Product
    FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling 3,594 bottles of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1440-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling specific lots of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1152-2014·2014-03-19

    Fougera Recalls Triamcinolone Acetonide Cream Due to Labeling Error

    Fougera Pharmaceuticals is recalling 493,192 tubes of Triamcinolone Acetonide Cream 0.1% because the end flap incorrectly displays 01% instead of 0.1%.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-241-2013·2013-04-10

    Fougera Recalls Ketoconazole Cream 2% Due to Unknown Degradant

    Fougera Pharmaceuticals is voluntarily recalling 60,210 units of Ketoconazole Cream 2% because an unknown degradant failed impurity specifications.

    Product
    KETOCONAZOLE — KETOCONAZOLE (KETOCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1426-2012·2012-08-01

    Fougera Recalls Erythromycin Topical Solution Due to Plasticizer Contamination

    Fougera Pharmaceuticals is recalling 444 bottles of Erythromycin Topical Solution USP, 2%, due to potential trace contamination with Di-Octyl Phthalate.

    Product
    Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.
    Category
    Drug
    Distribution
    Distributed nationwide